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The ArthroCare Coblator IQ System is indicated for the following procedures:

• For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in spinal and neurological procedures; and
• For ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
  • Adenoidectomy
  • Cysts
  • Head, Neck, Oral, and Sinus Surgery
  • Mastoidectomy
  • Myringotomy with Effective Hemorrhage Control
  • Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
  • Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
  • Neck Mass
  • Papilloma Keloids
  • Submucosal Palatal Shrinkage
  • Submucosal Tissue Shrinkage
  • Tonsillectomy
  • Traditional Uvulopalatoplasty (RAUP)
  • Tumors
  • Tissue in the Uvula/Soft Palate for the Treatment of Snoring

The ArthroCare Coblator IQ System is a bipolar, high frequency, electrosurgical generator called the Controller that is intended to be used with a family of disposable, bipolar, single use Wands.

The provided text is a 510(k) summary for the ArthroCare Coblator IQ™ System, an electrosurgical device. It outlines the device's description, intended uses, and claims of substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer all sections of your request.

Specifically, the document states: "performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Coblator IQ System to the predicate devices." However, it does not provide any specific acceptance criteria or the results of this performance testing in a quantifiable manner. It also does not define what "performance" specifically refers to in this context (e.g., coagulation efficacy, tissue ablation rate, etc.), nor does it provide the results of such tests or the methodology used to demonstrate the device meets any specific criteria.

Therefore, for many of your points, the answer will be that the information is not provided in the submitted text.

Here's a breakdown of what can and cannot be answered based on the provided text:

Acceptance Criteria and Device Performance

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Not specified	Not specified
   (The document states "performance testing has been completed to demonstrate the substantial equivalence," but does not list specific criteria or results.)	(The document claims "the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use" based on this testing, but provides no quantitative results.)

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample size: Not specified.
   • Data provenance: Not specified. (No information regarding the country of origin of data, or if it was retrospective or prospective.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This information is not applicable and not provided. The device is an electrosurgical tool, and the "performance testing" mentioned likely refers to bench testing or animal studies, not interpretative studies requiring expert ground truth in the way medical imaging AI devices do.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable and not provided. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • A MRMC study was not done. This type of study is relevant for diagnostic imaging AI, not for an electrosurgical device. The document does not describe AI assistance for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an AI algorithm. The device is a physical electrosurgical system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable. The concept of "ground truth" as used for AI/diagnostic devices doesn't directly apply here. The "performance testing" would likely involve objective measurements in a lab or animal model.

Training Set Details (Not applicable for this type of device)

8. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

9. How the ground truth for the training set was established:

   • Not applicable. See point 8.

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iQ-System PACS is a software device intended for viewing of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation. It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.

iQ-System PACS is a software device for network or web-based medical image viewing and manipulation, running on Windows 2000/XP. It is adapted for, storing, processing routing and report generating. iQ-System PACS fully supports the DICOM standard and has functionality for advanced DICOM viewing, Hanging Protocol, and 3D image processing (Orthogonal and Oblique Multiplanar Reconstructions (MPR), Maximum Intensity Projections (MIP), Surface Shaded Display (SSD), and Volume Rendering (VRT)). The main iQ-SYSTEM PACS modules are iQ-LITE, iQ-Print, iQ-View (including iQ-3D), and iQ-Web.

The provided text is a 510(k) summary for the iQ-System PACS. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about specific acceptance criteria or a study proving the device meets them in the way typically expected for performance-based AI/device evaluations.

This 510(k) is for a Picture Archiving Communications System (PACS) from 2006, which primarily deals with image viewing, manipulation, storage, and communication. At that time, the regulatory landscape and testing methodologies for PACS systems focused more on DICOM compliance, software functionality, and safety aspects rather than quantitative, statistically significant performance metrics like accuracy, sensitivity, or specificity for diagnostic tasks.

Therefore, many of the requested sections (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable or detailed in this type of submission.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria or performance metrics (like accuracy, sensitivity, specificity) for diagnostic tasks. The primary "acceptance criteria" for a PACS system like this, as implied by the 510(k) process, are:

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided. This document does not describe a clinical validation study involving a test set of medical images evaluated for diagnostic accuracy. The testing would have focused on software functionality, DICOM compliance, and safety.
• The document implies general medical imaging data (CT, MR, CR, DR, US) but does not specify a provenance for a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided. As no specific diagnostic performance test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set

• Not Applicable / Not Provided. No test set or ground truth adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This device is a PACS viewer, not an AI-assisted diagnostic tool. An MRMC study comparing human readers with and without AI assistance is not described and would not typically be performed for this type of general PACS system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable. The iQ-System PACS is a tool for human interpretation and management of images, not a standalone diagnostic algorithm. No standalone performance study is described.

7. The type of ground truth used

• Not Applicable / Not Provided. For a PACS system, ground truth in the diagnostic sense is not its direct function. Its "ground truth" relates to its ability to accurately display the source DICOM data. Compliance with DICOM standards and verification of image integrity are implicitly tested, but not framed as "ground truth" for diagnostic outcomes.

8. The sample size for the training set

• Not Applicable / Not Provided. This device is a software system for image management and viewing, not a machine learning or AI algorithm that requires a "training set" in the context of data-driven learning. Its development would involve software engineering and testing, not statistical training on medical images.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided. As it's not an AI/ML device, there's no concept of a training set or its associated ground truth.

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As with predicate devices indicated in this resubmittal (cardiac output monitors employing impedance plethysmography {DXG and DSB}), the IQ™ System is intended for use by qualified health care practitioners, under direction of a physician, for the non-invasive monitoring and management of cardiac function in a variety of medically accepted clinical applications. The IQ™ System (as well as predicate devices) is especially useful in cases where the invasive monitoring of cardiac output (e.g.: thermodilution) may compromise a given patient, is impractical, or otherwise contraindicated.

"IQ™ System" Cardiac Output Monitor

The provided document is a 510(k) clearance letter from the FDA for the "IQ™ System" Cardiac Output Monitor. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria or the study information usually found in a submission or a summary of safety and effectiveness data.

Therefore, I cannot provide the requested information based solely on the provided text. The document is essentially a regulatory approval letter, not a technical report or study summary.

To answer your request thoroughly, I would need to access the full 510(k) submission (K981720) itself, or a summary of safety and effectiveness that would typically accompany such a submission. This document only confirms the device's clearance and its intended use.

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